The present invention relates to fluid connectors, and more particularly to fluid connectors used in medical environments and designed to ensure the correct and appropriate administration of medicaments to a patient.
Errors in prescribing and delivering medications to patients are, unfortunately, common in medical practice. Many of these mistakes result in patient injury or death, and even if the patient recovers fully, the cost to society of induced and prolonged hospital stays and greater patient charges are staggering. It is estimated that at least 25,000 incidents involving drugs administered to a patient by the wrong route occur annually, all of which are the result of preventable human error. The most common cause of confusion in route of administration is the universal nature of medical connectors and injection sites. Most medical connectors and infusion/injection sites are universal couplers that are designed to mate with and therefore accept most syringes and other fluid delivering devices. The most common types of infusion sites are rubber septa designed to be pierced by a needle, and female luer connectors designed to be connected to a syringe or medical tubing with a male luer fitting, either by friction fit or threaded lock. Both types of sites are commonly included in intravenous infusion tubing, on the ends of heparin locks, in stopcocks in all types of intravenous, arterial, epidural, and other type connectors, and even in devices not designed for medication or fluid infusion at all, such as esophageal stethoscopes and urinary catheters. The universal employment of rubber septum injection ports and female luer connectors is directly coupled to thousands of errors in which a medication or fluid designed to be given by one route has inadvertently been given by another route, sometimes with disastrous consequences.
Several additional problems arise from use of current technology. The use of needles for connecting infusion lines and the administration of medicines has led to many cases of needlestick injury and transmission of blood borne infections, including hepatitis and AIDS. The infusion of proper fluids through the needle and coupler is also prone to inadvertent failure due to unwanted disconnection of the needle from the rubber septum. Moreover, repeated piercing of the coupler with the needle can taint the sterile fluid pathway.
The prior art has attempted to address the foregoing concerns by employing needleless systems and locking connectors, but they too are designed as universal connectors which are subject to route of administration errors. For example, a patient may be connected to multiple fluid delivering devices, hence forming multiple fluid pathways. The medical connectors are typically coupled to fluid delivering and receiving devices by universal type connectors, such as luer fittings. Hence, an attending person may accidentally apply a medicament to the wrong fluid pathway since the universal connector accepts or can be coupled to conventional fluid delivering devices.
It is an object of this invention to develop a needleless, relatively safe, locking connector system that is fluid path-specific. That is, the system should allow only infusions or injections of the proper type to be connected to the specific catheter or tubing type. In order to maintain efficiency and ease of locating the proper connectors, especially in an emergency, the types of connectors should be easily determinable by inspection.
Other general and more specific objects of the invention will in part be obvious and will in part appear from the drawings and description which follow.
The invention described herein is designed to eliminate, prevent or reduce the occurrence of unwanted or accidental administration of fluids to the wrong fluid pathway through known universal connectors. The present invention addresses this problem by replacing the universal connector with unique specially configured male/female connector pairs, each coded for use with only one type of medical catheter or device (e.g., peripheral intravenous catheter, central venous catheter, arterial catheter, epidural catheter, dialysis catheter).
The present invention specifically describes in one aspect a family of medical connectors designed to attach a medical infusion or injection device to a patient catheter or device. It is comprised of pairs of male-female locking connectors. The mating surfaces are uniquely indexed so that only complementary halves of the appropriate set connect together. Preferably, the fluid path runs through the length of the connector halves, with complementary shape- and/or size-indexed pieces constructed coaxially with the fluid path in each half connector. When in use, the two halves are pressed together and via a number of possible techniques locked into position, thus completing the fluid path. The ends of the connector halves opposite the mating surfaces can attach to standard luer-type medical connectors, preferably female on one half and male on the other, in order to interpose the mated connector between a catheter or other patient receiving device and an infusion or fluid delivering device, such as an intravenous tubing set or a syringe. In certain specialized applications, female-female, or male-male outer ends can be incorporated; in still others, non-luer fittings may be incorporated, for example to facilitate piercing a vial or intravenous fluid container.
According to another aspect of the invention, one half of the connector can be permanently attached to a catheter, infusion tubing set or syringe. This facilitates use of the device in applications which are especially sensitive to errors in fluid or medication administration, to ensure correct drug administration in emergency situations. In another aspect, a valve can be incorporated into either or both halves of the connector pair which closes the fluid path when the two halves are not mated together, or may incorporate irreversible locking mechanisms to attach the connector half permanently to a catheter, tubing end or syringe.
The present invention also provides for a medical connector suitable for use in coupling a fluid delivering conduit to a fluid receiving conduit, such as a catheter adapted for insertion within a patient. The medical includes first and second connector housing parts having a first end sized to mate with the fluid receiving and delivering conduits and a second end having a selected first surface feature formed thereon. When assembled, the first surface feature of the first housing part couples with the second surface feature of the second housing part to form a fluid connection therebetween.
According to one aspect, the first surface feature is sized and configured so as to only mate with the complementary shaped second surface feature to prevent another fluid delivering conduit having a differently configured surface feature from being connected to the fluid receiving conduit, thereby preventing the accidental administration of another fluid to the patient through the first and second housing parts.
According to one practice, the medical connector of the invention can employ a set of first and second medical connector housing parts, each having a differently shaped surface feature. Each housing part can also be adapted for connection at one end to the fluid receiving conduit and has a differently shaped surface feature formed thereon. Additionally, the selected surface feature formed on the second housing parts have a complementary-shaped surface feature. The first and second medical connector housing parts when assembled couple multiple fluid delivering conduits to multiple fluid receiving conduits such that only a particular fluid receiving conduit is coupled to a particular fluid delivering conduit.
According to another aspect, each medical connector housing part further includes a fluid conduit formed therein. When assembled, the first and second fluid conduits allow passage of a fluid therethrough and from the fluid delivering conduit to the fluid receiving conduit.
According to still another aspect, the first and second housing parts form a non-universal medical connector that inhibits universal connectors from coupling the fluid delivering conduit to the fluid receiving conduit. The medical connector can further include a locking element formed on at least one of the first and second medical connector housing parts for securing the housing parts part together.